MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number	I400+
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of calibration errors and questionable ise indirect gen 2 results from the cobas integra 400+ analyzer.The questionable results were reported outside of the laboratory and the physicians questioned them, as the results did not match the clinical condition of normal ambulatory patients.The customer sent the samples to another laboratory that used an abbott architect, and the results were all within the normal reference range.These results were deemed correct.One example was provided of an initial sodium result of 132 mmol/l and a repeat result of 138 mmol/l.The electrode lot number and expiration date were requested but were not provided.
Additional Manufacturer Narrative
The field service engineer could not determine a cause.He cleared the air mix/dry lines to the mix tower socket, and then disconnected and forced air through each one.He set the mix/dry to specifications.He ran precision testing and the customer ran ise calibration and qc with results within range.The analyzer alarm trace did not contain a conspicuous event.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS INTEGRA 400 PLUS
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15770125
• Report Number: 1823260-2022-03569
• Device Sequence Number: 6584273
• Product Code: JJE
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO THE ATTACHMENT.
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 66 KG